Personal data
title, name, first name / date of birth
nationality / languages
Field of operation valid for scope: MD
The above named person is
a full-time/part-time internal employee of the applicant
an external employee on freelance-basis/subcontractor
and is appointed as
QMS / site auditor / lead auditor
General requirements / requirements
QSZ / profile
auditor / comments
Successful completion of a bachelor university degree or a technical college degree or equivalent qualification in relevant studies, e.g. medicine, natural science or engineering
4 years in the field of healthcare products or related sectors (e.g. industry, audit, healthcare, research experience) whilst two years of this experience shall be in the area of quality management
Regulatory requirements of dir. 93/42/EEC, quality management system requirement in particular of standard EN ISO 13485, risk management (ISO 14971, FMEA methods), understanding of relevant harmonized standards
Preferably fulfil the qualification criteria for 3rd party auditors or experience as 2nd party or internal auditor
knowledge of ISO 19011 - for additional specialized requirements in accordance with the relevant standard specifications - evidenced by a recognized training organization and / or an in-house training by QSZ
Education / requirements
QSZ / profile
auditor / comments
biology or microbiology;
chemistry or biochemistry;
computer and software technology;
electrical, electronic, mechanical or bioengineering;
human physiology;
medicine;
pharmacy;
physics or biophysics.
Language skills: (verbally and in writing) / requirements
QSZ / profile
auditor / comments
German
Englisch
French
Knowledge and skills: / requirements
QSZ / profile
auditor / comments /
Knowledge of generic quality management system practices
Knowledge of specific management system standards, e.g. ISO 13485, GHTF documents etc.
Knowledge of legal framework of regulations and role of the CAB
Knowledge of medical device risk management, e.g. ISO 14971
Knowledge of CAB’s ISO 13485 processes
Knowledge of business management practices
Knowledge of Medical Device business/technology
Knowledge of client products, processes and organization
Language skills appropriate to all levels within the client organization
Note-taking and report writing skills
Audit-management skills
Knowledge and skills in EA scopes: / requirements
QSZ / profile
auditor / comments /
EA 4 / textile processing
Storage, processing (preparing, spinning, weaving, post processing), packaging, internal and external transport
EA 12 / chemical processing
mix / synthesize (batchwise or continuously), separating, cleaning, drying, bottling, storing
EA 13 / pharmaceutical processing
mix / synthesize (batchwise or continuously), separating, cleaning, drying, bottling, packaging, storage
EA 14 / plastic processing
Melting, forming, stamping, gluing, spraying, blowing, foaming, laminating, machining, packaging
EA 15 / glass/ceramic processing
mechanical processing
EA 18 / machinery/mechanical processing
Development, design, purchasing, testing, storage, transport, assembly, welding, coating
EA 19 / electronic/optics processing
Development, production, installation, maintenance, Populating, soldering, grinding, stamping, surface coating
EA 23 / other manufacturing
Woodworking, metalworking, plastics processing, surface treatment
EA 29 / distribution
Purchasing, storage, sales, maintenance, repair, disposal
Work Experience: / requirements QSZ / profile
auditor / comments /
closely related industries and the workplace such as research and development, manufacturing;
the application of the device technology and its use in health care services and with patients;
testing the devices concerned for compliance with the relevant national or international standards;
conducting performance testing, evaluation studies or clinical trials of the devices.
Advanced training elements: / requirements QSZ / profile
auditor / comments /
Risk management, including risk analysis according EN ISO 14971
Process validation;
Cleanroom/Sterilisation and related processes;
Electronics manufacture;
Plastics manufacturing processes;
Development and validation of software or hardware for devices and manufacturing processes;
In-depth knowledge of specific medical devices and/or technologies.
Remarks:
For completeness and correctness
______date /
______
date
______
signature auditor /
______
signature QS Zürich AG
File Name/Version erstellt Datum / author Freigabe Datum / Process Owner
FO 252-06-e MD self assessment auditor_vers01 31.01.15 / em xx.xx.xx / x Seite 2 von 2